|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 December 2023 |
|
Main ID: |
NCT02283229 |
|
Date of registration:
|
28/10/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Newborn Head Molding and Later Asymmetries
|
|
Scientific title:
|
Newborn Head Molding and Later Asymmetries in Follow up (3D Head Shape Modelling) |
|
Date of first enrolment:
|
February 2012 |
|
Target sample size:
|
135 |
|
Recruitment status: |
Enrolling by invitation |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT02283229 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Investigator).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Finland
| | | | | | | |
|
Contacts
|
|
Name:
|
Marita Valkama, Ph.D., M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Oulu, Oulu University Hospital |
|
|
Name:
|
Tuomo Heikkinen, Dos |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Oulu |
|
|
Name:
|
Henri Aarnivala, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Oulu |
|
|
Name:
|
Ville Vuollo, Ph.M. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Oulu |
|
|
Name:
|
Pertti Pirttiniemi, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Oulu |
|
|
Name:
|
Virpi Harila, Ph.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Oulu |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 1-6 days after birth;
- Healthy newborns in maternal ward, and living in near by Oulu region.
- Preterms at the age of 34-44 gestation weeks in near by Oulu region (non randomized)
Exclusion Criteria:
- Congenital anomalies,
- Very early discharge,
- Parental refusal
Age minimum:
1 Day
Age maximum:
6 Days
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Plagiocephaly
|
|
Intervention(s)
|
|
Behavioral: Newborns with preventive caring advices
|
|
Other: Newborns with normal caring advices
|
|
Primary Outcome(s)
|
|
Presence of Plagiocephaly (The number of children in groups with plagiocephaly (CI, OCLR =/> 104% )
[Time Frame: 3 months]
|
|
Secondary Outcome(s)
|
|
Change in plagiocephaly
[Time Frame: From 3 to 6 months]
|
|
Severity of plagiocephaly
[Time Frame: 3 months]
|
|
Change in facial symmetry
[Time Frame: from 10 years to 15 years]
|
|
Change in occlusal defects
[Time Frame: from 10 years to 15 years]
|
|
Change in occlusal defects
[Time Frame: from 6 years to 10 years]
|
|
Change in facial symmetry
[Time Frame: from 6 years to 10 years]
|
|
Occlusal defects
[Time Frame: 6 years]
|
|
Secondary ID(s)
|
|
EETTMK:27/2011
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|